A Phase 3 interventional study of Misoprostol in Abortifacient Agents, Nonsteroidal, Abortion, Incomplete and Misoprostol, sponsored by Madigan Army Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-02-08.
Sponsored by Madigan Army Medical Center · Phase 3, Interventional, and Prevention
The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.
Patients presenting to the OB/GYN clinic with a nonviable gestation, diagnosis documented by endovaginal ultrasound will be enrolled. Ultrasonic findings will be verified by two of the resident staff from the obstetrics and gynecology department of Madigan Army Medical Center. Patients consenting will be directed to the OB/GYN clinic for evaluation, exam, and counseling and to watch the video giving explanation of purpose of the study and the planned procedure, but also expected side effects and possible complications. Patients will be randomized into two groups: study group receiving Misoprostol per vagina and the control group receiving a placebo per vagina. Subjects will be issued an envelope and go to the pharmacy to pick up their study medication, blinded to them and the provider. They will also be given Motrin and Phenergan to help alleviate undesired side effects. Four 200 ug tablets of Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider. Patients will return in 24 hours for re-examination. If no evidence of an intrauterine pregnancy remains, patients will be informed that their miscarriage was complete, given precautions and asked to make an appointment for follow-up in 4 weeks in addition to weekly visits to the lab for quantitative BHCG. All patients will be followed until the quantitative BHCG has fallen zero to ensure resolution of the pregnancy event.
Patients with evidence of a gestational sac will be given a second dose of Misoprostol or a D\&C if they choose to withdraw from the study or a surgical intervention if it is deemed clinically indicated by the attending staff. Again, subjects will be given appropriate counseling and precautions and asked to follow up in an additional 24 hours for re-evaluation. Surveys will be given at each visit and follow up to evaluate patient satisfaction and also to query for unintended side effects and complications.
24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.
This study's enrollment of 30 is below the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.
Browse Abortion, Incomplete studies →Madigan Army Medical Center is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Four 200 ug tablets of Misoprostol
Drug: Misoprostol
Drug: Misoprostol
400 ug Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider.
Also known as: Cytotec
time to resolution
Time frame: 24hrs, and then weekly, after insertion
percentage requiring dilation and curettage
Time frame: 24hrs, and then weekly, after insertion
failure to expel products of conception
Time frame: 24hrs, and then weekly, after insertion
change in hematocrit
Time frame: 24hrs, and then weekly, after insertion
side effects
Time frame: 24hrs, and then weekly, after insertion
BHCG level
Time frame: 24hrs, and then weekly, after insertion
The record gives a start of Mar 1999, a primary completion of Oct 2006 and a completion of Oct 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Misoprostol
Madigan Army Medical Center